Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure

NCT02137187 | Unknown Phase 3 DMC

• 1 other identifier: CPMCV-01-14
• Study Type: interventional
• Target: 1,830
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality

Conditions

Permanent Atrial Fibrillation

Keywords

Atrial fibrillation; Heart failure; Catheter ablation; Cardiac resynchronization therapy; Implantable defibrillator

Outcome Measures

Primary Outcomes (1)

• Combined end-point

  "Morbidity trial" end-points Primary end-point: a combined of (1) mortality due to heart failure, (2) hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, or (3) worsening heart failure

  Upto 3 years

Secondary Outcomes (2)

• Major clinical events

  Up to 3 years

• Major clinical events

  Up to 5 years

Study Arms (2)

Drug therapy

EXPERIMENTAL

Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)

Drug: Optimized drug therapy; Device: ICD

Device: AV junction ablation & CRT

ACTIVE COMPARATOR

AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy

Procedure: AV junction ablation; Device: CRT; Drug: Optimized drug therapy; Device: ICD

Interventions

AV junction ablation PROCEDURE

AV junction ablation

Also known as: AV nodal ablation

Device: AV junction ablation & CRT

CRT DEVICE

Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)

Also known as: Cardiac resynchronization therapy

Device: AV junction ablation & CRT

Optimized drug therapy DRUG

Optimized drug therapy for heart failure and atrial fibrillation rate control

Also known as: Pharmacological therapy

Device: AV junction ablation & CRT; Drug therapy

ICD DEVICE

Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines

Also known as: Implantable defibrillator

Device: AV junction ablation & CRT; Drug therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible, each patient must be in the following condition:
• Permanent atrial fibrillation (\>6 months) which has been considered unsuitable for ablation or failed ablation
• Narrow QRS ≤ 110 ms
• Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control
• At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)

You may not qualify if:

• New York Heart Association (NYHA) class IV and systolic blood pressure \<80 mmHg despite optimized therapy;
• severe concomitant non-cardiac disease;
• need for surgical intervention;
• myocardial infarction within the previous 3 months;
• previous implanted devices (PM/ICD/CRT)

Sponsors & Collaborators

• Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella: lead

Study Sites (1)

Department of Cardiology, Ospedali del Tigullio

Lavagna, 16033, Italy

RECRUITING

Related Publications (4)

• Chatterjee NA, Upadhyay GA, Ellenbogen KA, McAlister FA, Choudhry NK, Singh JP. Atrioventricular nodal ablation in atrial fibrillation: a meta-analysis and systematic review. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):68-76. doi: 10.1161/CIRCEP.111.967810. Epub 2011 Dec 20.

  PMID: 22187425 BACKGROUND

• Brignole M, Botto G, Mont L, Iacopino S, De Marchi G, Oddone D, Luzi M, Tolosana JM, Navazio A, Menozzi C. Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial. Eur Heart J. 2011 Oct;32(19):2420-9. doi: 10.1093/eurheartj/ehr162. Epub 2011 May 23.

  PMID: 21606084 RESULT

• Brignole M, Pentimalli F, Palmisano P, Landolina M, Quartieri F, Occhetta E, Calo L, Mascia G, Mont L, Vernooy K, van Dijk V, Allaart C, Fauchier L, Gasparini M, Parati G, Soranna D, Rienstra M, Van Gelder IC; APAF-CRT Trial Investigators. AV junction ablation and cardiac resynchronization for patients with permanent atrial fibrillation and narrow QRS: the APAF-CRT mortality trial. Eur Heart J. 2021 Dec 7;42(46):4731-4739. doi: 10.1093/eurheartj/ehab569.

  PMID: 34453840 DERIVED

• Brignole M, Pokushalov E, Pentimalli F, Palmisano P, Chieffo E, Occhetta E, Quartieri F, Calo L, Ungar A, Mont L; APAF-CRT Investigators. A randomized controlled trial of atrioventricular junction ablation and cardiac resynchronization therapy in patients with permanent atrial fibrillation and narrow QRS. Eur Heart J. 2018 Dec 1;39(45):3999-4008. doi: 10.1093/eurheartj/ehy555.

  PMID: 30165479 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Cardiac Resynchronization Therapy; Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics; Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Claudio Marsano, MD

  Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

  STUDY DIRECTOR

Central Study Contacts

Michele Brignole, MD

CONTACT

+39 0185 329567; mbrignole@asl4.liguria.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2014
• First Posted: May 13, 2014
• Study Start: October 15, 2014
• Primary Completion: May 15, 2021
• Study Completion: July 31, 2021
• Last Updated: January 20, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)